Field of the Invention
The present application relates to a method for the preparation of a nanosuspension from natural materials, to a nanosuspension comprising at least one natural material, and the use of such nanosuspension for the preparation of a medicament.
Background of the Invention
Natural materials, such as plants, cyanobacteria, algae or fungi, contain active agents which have the potency for treating diseases. In order to elute these active agents from natural materials, a variety of pharmaceutical preparations are known including aqueous or alcoholic percolation or maceration, dried powder extracts in form of tablets or capsules, or injectable dosage formulations. However, there are many disadvantages associated with these types of administration. Many of the ingredients are degraded within the gastrointestinal tract or undergo first-pass metabolism in the liver. In addition, parts of the population experience difficulty swallowing pills or are unable to tolerate any solids. Furthermore, many active agents of natural materials are poorly water soluble. The potency and therapeutic effects of many active agents of natural materials are therefore limited.
U.S. Pat. No. 5,858,410 relates to drug preparations called “nano-suspensions” which are produced by high-pressure homogenization. Prior to the use of high pressure homogenization, nano-suspensions were prepared by a pearl milling process, which is a time consuming process compared to pressure homogenization. This technology is the subject of, inter alia, U.S. Pat. No. 5,271,944. A number of other methods have been used to prepare nano-suspensions with various degrees of success including low energy agitators, turbine agitators, colloid mills, sonolators, orifices, media mills, rotor stator mixers and sonicators.
Chinese patent application No. CN 1 416 847 A relates to a preparation of a nanosuspension of Radix Panacis Quinquefolii (American ginseng) produced by high-pressure homogenization at a concentration of between 20% and 11.1% (w/w).
European patent publication No. EP 2 226 171 A1 relates to a disintegration of wooden material (e.g. Douglas fir) by a millstone type grinder to provide cellulose fibers having an average fiber diameter of at most 30 nm and a corresponding cellulose fiber composite made thereof. The fibers have an average minimum length of 50 μm.
However, the prior art methods for preparing a nano-suspension lack a method for the preparation of a nano-suspension from natural materials with a high amount of natural material, i.e., a high concentration of natural material. There is thus still a need for methods for preparing a nano-suspension from natural materials, which nano-suspension may be advantageously used in the treatment or prevention of diseases.